Cleared Traditional

K250129 - AViTA Breast Pump

K250129 is an FDA 510(k) clearance for AViTA Breast Pump, manufactured by Avita Corporation. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 510-day FDA review.

K250129 · Avita Corporation · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
510d
Days
Class 2
Risk

K250129 is an FDA 510(k) clearance for the AViTA Breast Pump. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Avita Corporation (New Taipei City, TW). The FDA issued a Cleared decision on June 11, 2026 after a review of 510 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Avita Corporation devices

FDA 510(k) Submission Details - K250129

510(k) Number K250129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2025
Decision Date June 11, 2026
Days to Decision 510 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
350d slower than avg
Panel avg: 160d · This submission: 510d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGX Device Classification - Class 2, Special Controls

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGX Pump, Breast, Powered

All 135
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K250129.
DiscreetDuo™ Flow Wearable Breast Pump (Model S3)
K260259 · Shenzhen TPH Technology Co., Ltd. · Jul 2026
Wearable Breast Pump (Model S32A)
K261199 · Shenzhen TPH Technology Co., Ltd. · Jul 2026
Mother's Nature W1 Warming Wearable Breast Pump
K260864 · Shenzhen TPH Technology Co., Ltd. · Jun 2026
Spectra Platinum Mini
K260956 · Uzinmedicare Co., Ltd. · Jun 2026
eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)
K254300 · Anker Innovations Limited · May 2026
Wearable Breast Pump (Model S39)
K254244 · Shenzhen TPH Technology Co., Ltd. · May 2026